JANSSEN

Janssen Receives Positive CHMP Opinion for SYMTUZA™ The First Darunavir-Based Single-Tablet Regimen for the Treatment of HIV

Janssen-Cilag International NV (Janssen) today announced that the
Committee for Medicinal Products for Human Use (CHMP) of the European
Medicines Agency (EMA) has issued a Positive Opinion recommending
marketing authorisation for SYMTUZA™
(darunavir/cobicistat/emtricitabine/tenofovir alafenamide [D/C/F/TAF]),
a once-daily darunavir-based single tablet regimen (STR).

If approved, it will be the only darunavir-based STR indicated for the
treatment of human immunodeficiency virus type 1 (HIV-1) infection in
adults and adolescents aged 12 years and older with body weight of at
least 40 kg, with genotypic testing guiding use. This STR combines the
proven efficacy and durability of darunavir with the improved renal
laboratory and bone mineral density profile of F/TAF as compared to
F/TDF (tenofovir disoproxil fumarate), and will be the only treatment
that could deliver the adherence advantages of a STR coupled with the
high genetic barrier to resistance that darunavir offers.

“Darunavir is one of the most widely used HIV treatments in the European
Union due to its ability to control the HIV virus while offering a high
barrier to resistance. We will now be able to combine a complete
darunavir-based HIV treatment regimen into a once daily tablet. We are
extremely excited to be one step closer to getting this therapy to
people living with HIV and in doing so hope to reduce the treatment
burden faced by many living with the virus,” said Lawrence M. Blatt,
Ph.D., Global Therapeutic Area Head, Janssen Infectious Diseases
Therapeutics.

“A darunavir-based STR represents a significant evolution in treatment
options for HIV patients,” said Jean-Michel Molina, Professor of
Infectious Diseases at the University of Paris Diderot. “With around two
million people in Europe currently managing their HIV, this is a true
advancement in helping patients achieve an undetectable viral load and
improving quality of life. Reducing the pill burden allows people
greater freedom and flexibility, and through this we may also improve
treatment adherence.”

The Positive Opinion is based on a bioequivalence study comparing the
once-daily STR with the combined administration of the separate agents
darunavir [D] 800 mg, cobicistat [C] 150 mg, and emtricitabine/tenofovir
alafenamide [FTC/TAF] 200 mg/10 mg fixed-dose combination. A Phase 3
clinical trial programme investigating the efficacy and safety of the
darunavir-based combination is underway. Data on the bioequivalence
study, as well as interim data from the Phase 3 Pivotal EMERALD trial in
virologically suppressed antiretroviral therapy (ART) experienced
patients, who were switched to the STR, will be presented at the
upcoming International AIDS Society (IAS) conference in Paris, France.
Further EMERALD 48-week data, and 48-week data from the Phase 3 AMBER
trial in ART naïve patients, will be released in due course. Please
visit www.jnj.com/HIV
for further details on the breadth of science being presented by Johnson
& Johnson companies and its partners.

The CHMP's Positive Opinion will now be reviewed by the European
Commission, which has the authority to grant marketing authorisation for
medicines in the European Economic Area. The European Commission’s final
decision is anticipated in the coming months.

Janssen have brought medicines to market across a range of patient
populations that have helped to transform the efficacy and tolerability
of treatment. Treatment regimens that combine D/C (REZOLSTA®
,
Janssen-Cilag International NV, U.S name PREZCOBIX®
) and
F/TAF (DESCOVY®
, Gilead Sciences International Ltd) are
currently approved1,2
for the treatment of HIV. SYMTUZA™ is a
significant evolution of this approach, combining both treatments in a
single, convenient tablet, and is part of Janssen’s broader commitment
to develop effective and innovative therapies which address the issues
of adherence and resistance.

###

Notes to editors

On 23 December 2014, Janssen and Gilead Sciences International Ltd
amended a licensing agreement for the development and commercialisation
of a once-daily STR combination of darunavir and Gilead's TAF,
emtricitabine and cobicistat. Under the terms of the
agreement, Janssen and its affiliates are responsible for the
manufacturing, registration, distribution and commercialisation of this
STR worldwide.

About Janssen

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are
working to create a world without disease. Transforming lives by finding
new and better ways to prevent, intercept, treat and cure disease
inspires us. We bring together the best minds and pursue the most
promising science. We are Janssen. We collaborate with the world for the
health of everyone in it. Learn more at www.janssen.com/emea/
and follow us at @JanssenEMEA
.

About PREZISTA® (darunavir)

PREZISTA, co-administered with low dose ritonavir is indicated in
combination with other antiretroviral medicinal products for the
treatment of human immunodeficiency virus (HIV-1) infection in adult and
paediatric patients from the age of 3 years and at least 15 kg body
weight.

PREZISTA, co-administered with cobicistat is indicated in combination
with other antiretroviral medicinal products for the treatment of human
immunodeficiency virus (HIV-1) infection in adult patients.

In deciding to initiate treatment with PREZISTA co-administered with
cobicistat or low dose ritonavir, careful consideration should be given
to the treatment history of the individual patient and the patterns of
mutations associated with different agents. Genotypic or phenotypic
testing (when available) and treatment history should guide the use of
PREZISTA.

About REZOLSTA® (darunavir/cobicistat)

REZOLSTA is an antiviral medicine used, in combination with other
medicines, to treat adults with human immunodeficiency virus type 1
(HIV-1). REZOLSTA contains the active substances darunavir and
cobicistat. The medicine is for use only in patients who have not
received HIV treatment before or previously treated patients whose
disease is not expected to be resistant to darunavir and who are healthy
enough and have HIV virus levels below a certain threshold.

Cautions Concerning Forward-Looking
Statements

This press release contains "forward-looking statements" as defined
in the Private Securities Litigation Reform Act of 1995 regarding
development of potential preventive and treatment regimens for HIV. The
reader is cautioned not to rely on these forward-looking statements.
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underlying assumptions prove inaccurate or known or unknown risks or
uncertainties materialize, actual results could vary materially from the
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including uncertainty of clinical success and obtaining regulatory
approvals; uncertainty of commercial success for new indications and
therapeutic combinations; competition, including technological advances,
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product efficacy or safety concerns resulting in product recalls or
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laws and regulations, including global health care reforms; and trends
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these risks, uncertainties and other factors can be found in Johnson &
Johnson's Annual Report on Form 10-K for the year ended January 1, 2017,
including under “Item 1A Risk Factors,” its most recently filed
Quarterly Report on Form 10-Q, including in the section captioned
“Cautionary Note Regarding Forward-Looking Statements,” and the
company's subsequent filings with the Securities and Exchange
Commission. Copies of these filings are available online at www.sec.gov,
www.jnj.com
or on request from Johnson & Johnson. None of the Janssen Pharmaceutical
Companies or Johnson & Johnson undertakes to update any forward-looking
statement as a result of new information or future events or
developments.